(52 days)
No
The summary describes a system for tissue resection and coagulation with fluid and pressure control, and does not mention any AI or ML capabilities.
Yes
The device directly performs tissue resection and coagulation, which are therapeutic interventions.
No
The device is used for resection and coagulation of prostate adenomas, which is a treatment, not a diagnosis.
No
The device description explicitly lists multiple hardware components (Controller, Resectoscope, Fluid Control Set, Video Control Unit, Roll Stand, Waste Management Tubing, Tissue Catch) and the performance studies include hardware-related testing (Dimensional Inspection, Functional Testing for all components, Maximum LED Tip Temperature, Durability Testing, Thermal effects evaluation, Electrical Safety & EMC testing).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Veloxion System Function: The Veloxion System is a surgical device used for the physical resection (cutting) and coagulation (sealing) of prostate tissue within the body (in vivo). It also facilitates the removal of this tissue.
- Lack of Sample Analysis: The system does not analyze samples taken from the body to provide diagnostic information. Its function is entirely procedural and therapeutic.
The description clearly outlines a surgical system used for a procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.
Product codes
FJL, KQT, GEI
Device Description
The Veloxion System consists of the following components:
- Veloxion Controller (with Integrated Fluid Control)
- Footswitch
- Veloxion Resectoscope
- Veloxion Fluid Control Set
- Veloxion Video Control Unit
- Veloxion Roll Stand
The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes:
- Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
- Tissue Catch: For collection of gross resected tissue pieces for pathology.
The Veloxion System provides bipolar resection and coagulation of prostate adenomas, it distends the cavity by filling with saline and it provides pressure control of the cavity to facilitate viewing with the integrated Resectoscope. The components of Veloxion System perform the following functions:
- The Veloxion Controller provides bipolar radiofrequency outputs (for cut and coagulation) and fluid/pressure control through the use of two integrated peristaltic pumps, provides the user interface to establish the desired set pressure, monitors intracavitary pressure using dual independent pressure sensors mechanically connected to the Veloxion Fluid Control Set irrigation lumen. The software then monitors, controls and notifies the user when the limits are reached or when specific conditions are met.
- The Veloxion Resectoscope is a sterile single use hand held bipolar radiofrequency device configured to provide camera and light for visualization of the anatomy for the resection of tissue and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps.
- The Veloxion Fluid Control Set is a sterile single use device that provides conduits for fluid inflow, aspiration of resected tissue and fluids and a diaphragm (pressure membrane) that provides mechanism for the Controller to measure cavity pressure (through the irrigation lumen) during the procedure thereby facilitating the insufflation function.
- The Veloxion Video Control Unit provide control of the camera, light, display image to a commercially available monitor, stores image and video selected by the user from a session, and provides a USB connection for a USB Stick download of stored media by the user.
- The Veloxion Roll Stand enables monitoring of saline remaining in the saline bag.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained urologists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data have been provided in support of the substantial equivalence determination.
- Software Verification and Validation Testing performed per IEC 62304 and documentation provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Other Tests were performed per approved test protocols which included:
- Integrity: System withstands operating pressures
- Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control
- Dimensional Inspection and Testing
- Functional Testing for all components of the system
- Maximum LED Tip Temperature
- Comparative visualization testing in a simulated model
- Simulated Use: Tissue resection and spot coagulation of cavity pressure, imaging
- Durability Testing: Electrode durability testing for tissue resection and coagulation.
- Comparative testing to predicate for electrode durability, pressure control and fluid control.
- Thermal effects evaluation.
- Biocompatibility Testing: In accordance with ISO 10993-1
- Sterility: In accordance with ISO 11135:2014, ISO 11137-1:2006, ISO 11137-2:2013
- Packaging: In accordance with ASTM D4169:14 and ISO 11607-1:2006.
- Shelf-life: In accordance with ASTM F1980:2007.
- Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-18:2009 and IEC 60601-2-2:2009.
- Usability Testing: Use related risk evaluation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Veloxion System (cleared per K162979)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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March 15, 2019
Corinth MedTech, Inc. Sandeep Saboo Vice President, Quality Assurance and Regulatory Affairs 1601 S. De Anza Blvd, Suite 200 Cupertino, CA 95014
Re: K190099
Trade/Device Name: Veloxion System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FJL, KQT, GEI Dated: January 18, 2019 Received: January 22, 2019
Dear Sandeep Saboo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark R. Kreitz -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190099
Device Name Veloxion System
Indications for Use (Describe)
The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K190099: 510(k) Summary
I. Submitter Information
| Submitter name: | Corinth MedTech, Inc.
1601 S. De Anza Blvd, Suite 200
Cupertino, CA 95014 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Sandeep Saboo
Vice President, Regulatory Affairs and Quality Assurance
Phone: (408) 996-2517
Fax: (408) 996-0621 |
| Date Prepared: | 06 March 2019 |
II. Product Classification
| Device Name: | Veloxion System | |
|---|---|---|
| Common Name: | Resectoscope | Subject Device |
| Regulation: | 21 CFR 876.1500 | |
| Regulation Name: | Endoscope and accessories | |
| Class: | II | |
| Product Code: | FJL | |
| Additional Product Codes: | KQT, GEI |
III. Predicate Devices
The predicate device is the system comprised of the following legally marketed devices as used in combination to which substantial equivalence is claimed: Primary Predicate: Veloxion System (cleared per K162979)
Predicate has not been a subject of a design related recall.
IV. Device Description
The Veloxion System consists of the following components:
- · Veloxion Controller (with Integrated Fluid Control)
- o Footswitch
- · Veloxion Resectoscope
- · Veloxion Fluid Control Set
- · Veloxion Video Control Unit
- · Veloxion Roll Stand
The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes:
- · Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
- · Tissue Catch: For collection of gross resected tissue pieces for pathology.
The Veloxion System provides bipolar resection and coagulation of prostate adenomas, it distends the cavity by filling with saline and it provides pressure control of the cavity to facilitate viewing
4
with the integrated Resectoscope. The components of Veloxion System perform the following functions:
- The Veloxion Controller provides bipolar radiofrequency outputs (for cut and coagulation) and fluid/pressure control through the use of two integrated peristaltic pumps, provides the user interface to establish the desired set pressure, monitors intracavitary pressure using dual independent pressure sensors mechanically connected to the Veloxion Fluid Control Set irrigation lumen. The software then monitors, controls and notifies the user when the limits are reached or when specific conditions are met.
- · The Veloxion Resectoscope is a sterile single use hand held bipolar radiofrequency device configured to provide camera and light for visualization of the anatomy for the resection of tissue and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps.
- · The Veloxion Fluid Control Set is a sterile single use device that provides conduits for fluid inflow, aspiration of resected tissue and fluids and a diaphragm (pressure membrane) that provides mechanism for the Controller to measure cavity pressure (through the irrigation lumen) during the procedure thereby facilitating the insufflation function.
- · The Veloxion Video Control Unit provide control of the camera, light, display image to a commercially available monitor, stores image and video selected by the user from a session, and provides a USB connection for a USB Stick download of stored media by the user.
- · The Veloxion Roll Stand enables monitoring of saline remaining in the saline bag.
V. Indications for Use
There is no difference in the indications for use for the subject device when compared to the predicate device
| Device | Indications For Use |
|---|---|
| Modified Veloxion | |
| System | |
| (Subject Device) | The Veloxion System is intended for use by trained urologists for |
| endoscopically controlled tissue chip resection and coagulation, and | |
| removal of prostate adenomas via suction channel under continuous flow | |
| conditions following resection using a bipolar resecting device. | |
| Veloxion System | |
| K162979 | |
| (Predicate Device) | The Veloxion System is intended for endoscopically controlled tissue chip |
| resection and coagulation and removal of prostate adenomas via suction | |
| channel under continuous flow conditions following resection using a | |
| bipolar resecting device. |
Comparison of Indications for Use
VI. Comparison of Technological Characteristics with the Predicate Device
The subject Veloxion System and the previously cleared Veloxion System (K162979) have the same or similar technological characteristics in terms of basic operating principle and basic design features with one key difference being that the subject Veloxion System includes a sterile, single use camera and light while the predicate Veloxion System uses a commercially available reusable Endoscope.
5
Veloxion System Traditional 510(k) Premarket Notification
| Technological Characteristics | Modified VELOXION SYSTEM
(Subject) | VELOXION SYSTEM
(Predicate K162979) |
|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Monopolar or Bipolar | Bipolar | Bipolar |
| Energy Type: | Radiofrequency, Bipolar | Radiofrequency, Bipolar |
| Optics: | Integrated, Sterile, 10degree Endoscope | Compatible with reusable 30° marketed Endoscope |
| Able to Set Cavity Pressure on the Device? | YES | YES |
| Continuous Flow? : | YES | YES |
| Irrigation fluid: | Saline | Saline |
| Pump? | Dual Pump (Irrigation, Aspiration) | Dual Pump (Irrigation, Aspiration) |
| Able to Monitor saline remaining?: | YES | YES |
| Programmed Flow Rate: | Programmed flow rate constant for each mode:
Steady State = 50ml/min,
Cut = 380ml/min
Coag = 50ml/min
ASPIRATE = 400ml/min | Programmed flow rate constant for each mode:
Steady State = 100ml/min,
Cut = 380ml/min,
Coag = 100ml/min
ASPIRATE = 750ml/min |
| Passive Flow: | User adjustable flow rate using Roller Clamp installed during
manufacturing. The nominal passive flow rate when Roller Clamp
is fully open is:
• 360ml/min (at 20mmHg)
• 500ml/min (at 60mmHg) | No passive flow |
| Set Pressure Range: | 20 to 60mmHg | 10 to 60mmHg |
| Positive Action to Increase Above 40mmHg: | YES | YES |
| Pressure Sensor: | Dual, independent, direct sensing of cavity pressure | Dual, independent, direct sensing of cavity pressure |
| Over-pressure condition detection: | YES | YES |
| Maximum Allowable Actual Cavity Pressure | 75mmHg | 75mmHg |
| Ultimate mitigation for risk of over-pressurization of
cavity if all designed mitigations are unsuccessful | • Non-defeatable, continuous notification tone
• Notification displayed:
"Remove device from cavity. Check for Clog." | • Notification tone
• Notification displayed:
"Remove device from cavity. Check for Clog." |
| Max. Shaft OD (Sheath): | With Sheath Assembled: 25Fr (8.3mm) | With Sheath Assembled: 26Fr (8.6mm) |
| Working Length: | Sheath Working Length: 220mm | Sheath Working Length: 193mm |
| Materials (Electrode/ Insulation): | Electrode: Tungsten (99.95% purity)
Insulation: FEP | Electrode: Tungsten (99.95% purity)
Insulation: FEP |
| How Supplied (Sterility): | Sterile, Single Use
(Veloxion Resectoscope) | Sterile, Single Use
(Veloxion Resecting Device Kit) |
6
The main technological differences between the subject Veloxion System and the predicate Veloxion System are the following:
- The subject Veloxion System includes a sterile, single-use camera and light system while the predicate Veloxion System uses a commercially available reusable Endoscope.
- The subject Veloxion System includes programmed flow rates that are slightly different than the predicate Veloxion System as a result of an integrated passive flow mechanism.
The differences outlined were evaluated through performance testing to demonstrate safety and effectiveness of the subject Veloxion System.
VII. Non-Clinical Testing Data
The following performance data have been provided in support of the substantial equivalence determination.
- Software Verification and Validation Testing performed per IEC 62304 and . documentation provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Other Tests were performed per approved test protocols which included: ●
- o Integrity: System withstands operating pressures
- Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control O
- Dimensional Inspection and Testing O
- Functional Testing for all components of the system O
- Maximum LED Tip Temperature O
- Comparative visualization testing in a simulated model O
- Simulated Use: Tissue resection and spot coagulation of cavity pressure, O imaging
- Durability Testing: Electrode durability testing for tissue resection and coagulation. O
- Comparative testing to predicate for electrode durability, pressure control and fluid O control.
- Thermal effects evaluation. O
- Biocompatibility Testing: In accordance with ISO 10993-1 O
- Sterility: In accordance with ISO 11135:2014, ISO 11137-1:2006, ISO 11137-2:2013 O
- Packaging: In accordance with ASTM D4169:14 and ISO 11607-1:2006. O
- Shelf-life: In accordance with ASTM F1980:2007. O
- Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-O 2:2014, IEC 60601-2-18:2009 and IEC 60601-2-2:2009.
- Usability Testing: Use related risk evaluation o
- o Integrity: System withstands operating pressures
VIII. Conclusions
Based on the results of performance tests, the subject Veloxion System is considered to be substantially equivalent and as safe and effective as the predicate Veloxion System (K162979).